Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Pointe Scientific, Inc., is recalling all size kits of its Liquid Glucose Hexokinase Reagent catalog number G7517, after the reagents were found to fail linearity at the >200 mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent (G7517) should destroy the remaining inventory.

The affected lots were distributed nationwide to medical device distributors and testing laboratories nationwide. The recall includes the following lot numbers and has the following expiration dates:

Lot # 823901 (all batches) Expiration: 2010-02
Lot # 826801 (all batches) Expiration: 2010-03
Lot # 829401 (all batches) Expiration: 2010-04
Lot # 831502 (all batches) Expiration: 2010-05

Catalog numbers: G7517-120 (97 kits), G7517-500(129 kits), G7517-1L (31), 8-G7517-120 (15 vials), 8-G7517-500 (21vials), 3-G7517-L (28L), 7-G7517-500 (5 vials). 7-G7517-1000 (3bottles), with the following lot numbers:

Lot #814301 (all batches) Expiration: 2009-11
Lot# 820502 (all batches) Expiration: 2010-01

Testing laboratories that have received the products should inform the patient’s attending physician and determine, with their input, whether confirmation of the previous test results will be required. To date, no injuries or inaccurate results associated with the reagents have been reported to the firm.

Pointe Scientific, Inc. has notified its distributors and drop-ship customers and is arranging for replacement of all recalled products. Distributors and testing laboratories with questions may contact the firm at 1-800-445-9853. Adverse events or quality problems experienced with use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

This entry was posted on Thursday, November 5th, 2009 at 7:00 am and is filed under product liability, recalled products. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.